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New treatment option for Intensive Care Units, Pediatric
Official title Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents
ClinicalTrials.gov ID: NCT05867472
What this study is testing
What is Isoflurane Inhalant Product?
Isoflurane Inhalant Product is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for intensive care units, pediatric.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of a pilot study is to test a study plan to see if it is appropriate for a larger study. This study plan is looking at whether the use of inhaled sedatives (medications that help people be calm and sleep) can reduce delirium (extreme confusion) in children who need a ventilator (breathing machine) compared to IV or oral sedatives.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- Pediatric patients age from 1 month to less than 18 years who need sedation to tolerate mechanical ventilation and will remain ventilated for ≥ 24...
- Receiving IV sedation by infusion or bolus for ≤72h to aid mechanical ventilation (but will be recruited as early as possible)
You likely can't join if
- Current use of inhaled prostacyclin (high viscosity of prostacyclin impairs vaporizer device) or continuous salbutamol nebulization (impairs gas...
- Family history or personal history of malignant hyperthermia (MH)
- Allergy to isoflurane, sevoflurane or other volatile inhaled anesthetic gas
- Metabolic, mitochondrial or myopathy disease e.g., Duchenne muscular dystrophy (volatiles may trigger malignant hyperthermia like reaction)
- Moribund with expected survival \< 24h
- Known pregnancy or lactation
See the full eligibility criteria
- Pediatric patients age from 1 month to less than 18 years who need sedation to tolerate mechanical ventilation and will remain ventilated for ≥ 24 hours
- Receiving IV sedation by infusion or bolus for ≤72h to aid mechanical ventilation (but will be recruited as early as possible)
- Current use of inhaled prostacyclin (high viscosity of prostacyclin impairs vaporizer device) or continuous salbutamol nebulization (impairs gas analyzer function)
- Family history or personal history of malignant hyperthermia (MH)
- Allergy to isoflurane, sevoflurane or other volatile inhaled anesthetic gas
- Metabolic, mitochondrial or myopathy disease e.g., Duchenne muscular dystrophy (volatiles may trigger malignant hyperthermia like reaction)
- Moribund with expected survival \< 24h
- Known pregnancy or lactation
- Suspected or evidence of high intracranial pressure (ICP)
- Not a 'closed ventilator circuit' with potential for gas leak (e.g. uncuffed ETT, bronchopleural fistula, tracheal/trachea-esophageal fistulas, or other sources of "gas leak" from patient circuit that cannot be removed)
- Prior enrollment in the ABOVE trial
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada; London, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.